Field of the Invention
The present patent application is generally related to medical devices used during surgical procedures and is more specifically related to sterile packaging systems for medical devices.
Description of the Related Art
During surgical procedures, great care is taken to prevent contamination of the surgical tools and medical devices used during the course of an operation. An operating team typically includes at least one member whose function is to open packages containing surgical tools and medical devices and to present them to a sterile nurse or surgeon in a manner in which they remain in a sterile condition.
In many instances, sealed pouches, such as sealed foil laminate pouches, are used for dispensing sterile medical devices and products. For some medical devices, for example, those that require a high degree of moisture protection, laminate pouches having foil barriers are necessary. Many surgical nurses prefer sealed pouches having large opening flanges with chevron shaped seal lines for ease of aseptically opening and dispensing a medical device in a sterile field. All packages are susceptible to being dropped and mishandled, which results in package integrity failures in certain instances. In addition, foil laminate pouches, especially when used for three-dimensional devices (e.g., a device having a thickness of one or more inches), are more susceptible than two-dimensional foil laminate pouches to package integrity breaches (e.g., holes) when the pouch in certain instances is damaged in processing and handling and then when hard wrinkles subsequently develop, which can break open during transit conditions (e.g., vehicle vibration).
Some medical devices require packaging that provides moisture protection so that excessive moisture does not build up within the sterile package, which could degrade the performance and/or efficacy of the medical device or components contained within the medical device. Typically, a moisture-absorbing card may be used to support the medical device before the card and the medical device are inserted into a pouch, which is sealed to provide a sterile environment inside the package.
FIG. 1 shows a card 20 having medical device securing elements 22A, 22B that are used to secure a medical device 24 over a top surface of the card 20. The card 20 has a leading end 26, a trailing end 28, and a generally rectangular shape. The corners of the card 20 at the leading and trailing ends 26, 28 are rounded. The card may be made of a moisture-absorbing material such as paperboard or of a more robust and inert polyethylene material.
The card 20 is designed to support and secure a medical device 24 having a length, a width, and a thickness. The medical device 24 is not flat and constitutes a three-dimensional (3D) structure that sits atop of the card 20. The medical device 24 is secured to the card 20 via the medical device securing elements 22A, 22B.
Referring to FIGS. 1 and 2A, during a packaging procedure, the leading end 26 of the card 20 is inserted into a sealable foil pouch 30. Referring to FIG. 2A, the foil pouch 30 has three sealed sides 32A, 32B, and 32C, and an open, unsealed side 32D. Typically, the leading end 26 of the card 20 is inserted into the open end 32D of the foil package 30 so that the leading end 26 is adjacent to the sealed end 32B and the trailing end 28 of the card 20 is nearest the open end 32D. A heat seal 34 is then formed adjacent the proximal end of the foil package 30 to fully seal the card 20 and the medical device 24 within the foil pouch 30.
Referring to FIGS. 2A and 2B, during handling and shipment, hard wrinkles or hard pinches may develop in the sealed foil pouch due to the three-dimensional (3D) nature of the medical device positioned within the foil pouch. Hard wrinkling or hard pinches of the foil pouch may be further impacted during shipment of the packages and due to mechanical forces such as vibration. FIGS. 2A and 2B show a foil pouch 30 having wrinkles 36 or hard pinches that may result in the formation of integrity breach holes 38. When testing and evaluating packaging, it has been observed that hard wrinkling of the foil pouch can potentially cause foil integrity failure due to the formation of pin holes 38 or other defects, which destroy the integrity and sterile environment inside the package. The integrity breach holes 38 may have a diameter of about 25-50 microns.
It is believed that one cause of wrinkling of the foil pouch 30 is because the card 20 and the medical device 24 do not completely fill the interior of the foil pouch, which allows the foil pouch to collapse inwardly around the sides of the three-dimensional medical device.
In view of the above-identified deficiencies found in conventional packaging systems for medical devices, there remains a need for packaging systems having medical device cards that completely fill the interior of a foil pouch, that keep the pouch smooth, and that prevent hard wrinkling and pinching of the pouch, which could result in failure of the sterile packages.